What is the Feasibility, Acceptability and Sensitivity of the iSTEP Exercise Test in Boys With Haemophilia?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Feasibility of the study protocol, as measured by recruitment success.
研究概览
简要总结
This study will be used to assess the feasibility and sensitivity of using the iSTEP, to assess exercise capacity in boys with haemophilia.
The feasibility criteria to be explored includes:
- Recruitment to target number or better
- The test procedure is completed within an allocated time (1-2 hours) and by 90% of participants without serious adverse events
- 90% of participants achieve a sufficient exercise response (85% maximum heart rate (HRmax))
- Calculation of estimates of minimum clinically important differences and variability for sample size calculations and responsiveness to severity of haemophilia and orthopaedic status The iSTEP exercise test will be compared to a more commonly used exercise test the modified shuttle walk test (10m- MSWT). Muscle strength (using myometry) will also be tested and compared to exercise performance for any relationships. Physical activity levels will also be assessed to obtain some baseline measurements of physical activity levels in this patient population, which are currently not very well known. The overarching aim of this current study is also to establish a robust and sensitive exercise test and to gain an understanding of the effects of physical activity levels and muscle strength on exercise capacity in this population.
详细描述
Identification of potential participants Eligible participants will be identified from the clinical patient database in the Haemophilia Centre at Great Ormond Street Hospital (GOSH) for Children NHS Trust. Potential participants will then be randomly selected. A simple randomisation approach will be employed using a computer random number table to select potential participants from the database. The parents / legal guardians will then be approached initially by the investigator via telephone to provide a brief verbal explanation of the research study and ask if they would be happy to receive a patient information sheet prior to their next clinic appointment. Should they be interested in participating in the study they will receive, by post, the PIS (one for parents and a separate age appropriate version for children) at least one week prior to their next clinic appointment. This will allow for a 'cooling-off' period of a minimum of one week for the potential participants. The researcher will then be available for questions by telephone or at the participant's next clinic appointment.
For the normal healthy control exercise test comparison population, data will be obtained from the existing iSTEP healthy control data collected as part of the iSTEP study from children in primary schools in London. This sample of 30 participants will be matched to the haemophilia group in terms of sex, age, body mass and stature.
Participant Recruitment
Consent of participants:
Most study recruits will be unable to give consent to participate due to their age. If the family have indicated that they are interested in participating in the study then at an agreed time (likely the next clinic appointment) one of the investigators from the research team will meet with the child participant and parent / legal guardian to complete the consent and assent forms as appropriate. The investigator will further explain the study procedures to the parent and child, why they are being asked to consider to be a part of the study and the associated risks and benefits of being included. The parent and child will then be given an opportunity to ask any further questions. The child/parent/legal guardian will then be asked to confirm if they agree to take part in the study. If consent is agreed a parental consent form will be completed by the parent/guardian and a copy will be provided. If the child assents then they will be asked to sign an assent form. If at any point during the study process the parent/guardian does not consent to inclusion in the study or the child withdraws their assent, then any data collected will be destroyed. Any decision to refuse or withdraw from the study will in no way influence the services that they receive.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 15 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Boys with mild, moderate and severe haemophilia aged 6 - 15 years (haemophilia A or B)
- •Inhibitor or non-inhibitor
- •Child able to follow simple verbal instructions, provide informed consent or assent
排除标准
- •Child has a past history of acquired brain injury
- •Child has a past history of any other disturbance of the central nervous system
- •Joint or muscle bleed in the lower limb in the past 6 weeks
- •Presence of lower limb pain on day of testing
- •Diagnosis of severe asthma or exercise induced bronchoconstriction
研究组 & 干预措施
iSTEP Feasibility Study Protocol
All participants will be asked to undergo the entire protocol: iSTEP exercise test, 10 metre incremental shuttle walk test, myometry, accelerometry and Haemophilia Joint Health Score.
干预措施: iSTEP exercise testing (Other)
结局指标
主要结局
Feasibility of the study protocol, as measured by recruitment success.
时间窗: 10 months
Percentage of participants recruited from the number of approached.
Safety and Acceptability of the study protocol, as measured by the occurrence of any serious adverse events or reactions.
时间窗: 10 months
Evaluate whether the test procedure is completed within the allocated time (1-2 hours) without serious adverse events in \>90% of participants.
次要结局
- Pain before, during, immediately post and 3 mins post exercise tests(5 minutes)
- Time spent in moderate to vigorous activity(7 days)
- Muscle Myometry(15 minutes.)
- Haemophilia Joint Health Score (HJHS) 2.1(30 minutes.)
- Duration exercise test completed in.(Typically, up to 15 minutes.)